HERPET- A Novel PET Imaging Study of HER2 in Breast Cancer

Status Recruiting

Clinical Trial Summary

This mechanistic study will be the first study to assess the efficacy of [18F]GE-226 to target HER2 expression in patients with metastatic breast cancer. The study will establish the pharmacokinetics of [18F]GE-226 and the optimum time-point for performing static scans in this patient population.

Clinical Trial Description

Objectives Primary: - To determine the uptake in tumour lesions and normal tissue of [18F]GE-226 and compare the difference between patients with HER2 positive and HER2 negative lesions. Uptake will be quantified by semi-quantitative (SUV, AUC) and fully quantitative parameters (Ki in the case of irreversible uptake, and binding potential in the case of reversible uptake) - To determine the optimal imaging time point for [18F]GE-226 Secondary: - To determine the safety and toxicity of [18F]GE-226 PET in humans - To determine if [18F]GE-226 can distinguish between HER2 amplified and HER2 non-amplified breast tumours - To determine the metabolism of [18F]GE-226 in human subjects Exploratory: • To explore circulating biomarkers that may be related to [18F]GE-226 uptake and to investigate if treatment modulates [18F]GE-226 Endpoints Secondary: - Safety and toxicity of [18F]GE-226 measured by adverse events from administration of [18F]GE-226 injection throughout the study period, and clinically significant changes from baseline measurements in serum biochemistry, haematology, coagulation, immunology, urinalysis, vital signs, ECG, injection site and physical examination findings. - The association between [18F]GE-226 tumour uptake and standard HER2 pathological testing (HER2 amplified and HER2 non-amplified breast tumours) - Proportion of metabolised [18F]GE-226 at scheduled time-points compared to baseline - Normal tissue uptake of [18F]GE-226 will be quantified in the appropriate regions depending on the field of view. Exploratory: • To perform preliminary biodistribution analysis, to compare [18F]GE- 226 uptake to [18F]FDG uptake in tumour lesion ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03827317
Study type	Interventional
Source	Imperial College London
Contact	HERPET Trial Coordinator
Phone	0207 59 42804
Email	herpet@imperial.ac.uk; g.gopalakrishnan@imperial.ac.uk
Status	Recruiting
Phase	N/A
Start date	March 8, 2019
Completion date	December 31, 2023

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.